RegWardenFDA facility compliance records
Recall

Class II — Mizuho America, Inc.

Recalling firmMIZUHO AMERICA, INC.
Registered facilityMIZUHO AMERICA, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonSpecific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, are discolored.
ProductMizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
Quantity35
DistributionNationwide Distribution
Initiated2013-10-10
Classified2013-11-22
Terminated2014-01-13
Recall numberZ-0378-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Mizuho America, Inc. (Z-0378-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66561/

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